BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT BRIDLE PRO

    MDR report key: 8135220 · Received December 5, 2018

    Report

    Report Number
    1526012-2018-00008
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    February 1, 2018
    Report Date
    December 3, 2018
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY INC.
    Product Code
    KNT
    PMA / PMN Number
    K142971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A RESPONSE TO USER FACILITY REPORT # (B)(4). WE HAVE ASSIGNED COMPLAINT # (B)(4) TO THIS REPORT. THE USER FACILITY REPORTED THAT THE DEVICE WAS NOT AVAILABLE FOR RETURN THEREFORE AN ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED AND DEVICE FAILURE COULD NOT BE CONFIRMED. A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED AS THE DEVICE WAS NOT RETURNED, NO LOT NUMBER WAS REPORTED WITH THE COMPLAINT, AND THIS TYPE OF DEVICE DOES NOT INCLUDE A LASERED LOT NUMBER. BASED ON THE PROVIDED INFORMATION THE REPORTED INCIDENT IS NOT BELIEVED TO HAVE BEEN CAUSED BY A MANUFACTURING DEFECT. WE WILL PROVIDE ADDITIONAL INFORMATION TO THE FDA IF THE DEVICE OR ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED AND ITS ANALYSIS CHANGES THE CONCLUSION OF THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT HAD BRIDLE PRO AS DOBHOFF TUBE ANCHOR IN PLACE. THE GREEN/BLUE PLASTIC TUBING HOLDING IT INTO THEIR NASAL SEPTUM WAS CUTTING INTO THE TISSUE OF THEIR NOSE. MD NOTIFIED AND ORDERS RECEIVED TO REMOVE BRIDLE LEAVING DOBHOFF TUBE IN PLACE. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975599 AMT BRIDLE PRO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY INC. 4-42

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention